The Role of C-11 Choline PET in Patients With Prostate Cancer
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The investigators determine the target number as 54 patients based on the following reasons:
(a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to
99.9 ng/ml was 21% (166/767 cases in a systemic review) [8]; the estimated sample size would
be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI
scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming
a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic
number for the high risk prostate cancer patients in our hospital annually is ~70, about 6
patients a month. It is clinically feasible to recruit 3 patients a month until 18 months
since the study begin. The study could be completed in 2 years with 54 cases